The Effects of Whole Food Intervention on Mucositis in Patients Treated for Head and Neck Cancer

Mucositis Clinical Trial

Official title:

The Effects of Whole Food Intervention on Mucositis in Patients Being Treated for Head and Neck Cancer With Radiation With or Without Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02575313
• Other study ID #: 07-173B
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 25, 2015
• Last updated: October 9, 2015
• Start date: October 2009
• Est. completion date: September 2012

Study information

• Verified date: October 2015
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter, honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and neck cancer patients undergoing standard treatment.

Description:

The proposal is a one center, open label, randomized pilot study to evaluate the safety, tolerability and compliance of a Whole Food Intervention with Standard of Care for patients with head & neck cancer. The primary objectives are:

1. To determine whether patients will use a Whole Food Intervention 4-6 times daily, and

2. To determine whether the Whole Food Intervention will reduce the incidence of grade 2 or greater mucositis from 75% historically seen to 25% .

3. To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from >19% to < 10% (see section 9 for comments)

This Whole Food Intervention will be taken by mouth before the start of radiation therapy, with or without chemotherapy and for the entire treatment therapy.

Mucositis-related pain and reduction of oral intake will be quantified by using validated assessment tools. Weight loss or gain, diarrhea, constipation or no change in bowel function and the use of conventional medication for radiation-induced mucositis will be recorded. Chart review and patient questionnaires will be used to establish whether a treatment break or dose reduction for radiation of chemotherapy was required due to radiation mucositis-related symptoms. Complete Chemistry Profile and Complete Blood Count will be extracted from the patients' medical oncologist's or radiation oncologist's records. The patient will continue to use standard mucositis therapies if desired as prescribed by the treating oncology physician.

The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3 portioning cups, equal to approximately 12 ounces, taken daily before starting radiation therapy. A questionnaire will be used to record symptoms and doses taken. The patient will continue to use standard mucositis therapies as prescribed by the treating oncology physician.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histopathologically confirmed diagnosis of head & neck carcinoma

• Scheduled to undergo continuous daily course of radiation therapy with or without chemotherapy

• No other serious concurrent medical illness as determined by the Principle Investigator

• Absolute neutrophil count = 500/mm3

• Platelet count = 50,000/mm3

• No history of insulin-dependent diabetes mellitus

• No prior hypersensitivity reaction to compound components

Exclusion Criteria:

• Dislike of the available forms of the WFI

• Allergy or food intolerance relevant to the ingredients

• Lack of access to refrigerated storage for the WFI

• Inability or unwillingness to participate twice a week

• Inability to swallow

• Undergoing treatment for HIV with HIV medications

• Ongoing alcohol and/or drug abuse

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis

Intervention

Dietary Supplement:
• Whole Food Intervention
A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.

Locations

Country	Name	City	State
United States	Integrative Medicine Program, Providence St. Vincent Medical Center	Portland	Oregon
United States	The Oregon Clinic, Providence Portland Cancer Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Tolerability	Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants.	Eight (8) weeks	No
Secondary	Mucositis Grading	Mucositis grade was calculated using established criteria.	Eight (8) weeks	No
Secondary	Treatment Break Measurement	To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from =19% to =10%.	Eight (8) weeks	No